Invivo Essential 865353 User manual

*989803173791*
989803173791
Essential MRI Patient Monitor
(Model 865353)
Instructions for Use
989803173791 Rev 0.6
English

2 989803173791 Rev 0.6

989803173791 Rev 0.63
Manufacturer
InvivoCorporation
Orlando,Florida32826
U.S.A.
(407)275‐3220
(800)331‐3220
www.invivocorp.com
Copyright
Copyright©2010,Invivo.Allrightsreserved.PrintedintheUnitedStates.
REF989803173791Rev.A,October2010
Equipment Classification
NOTE
LawsintheUnitedStatesrestrictthisdevicetosalebyorontheorderofaphysician.
EQUIPMENTCLASSIFICATION(accordingtoIEC60601‐1)
Accordingtothetypeofprotection
againstelectricalshock ClassIequipment
Accordingtothedegreeofprotection
againstelectricalshock: TypeCF(defibrillator‐proof)equipment
Accordingtothedegreeofprotection
againstharmfulingressofwater:
IPX2(enclosedequipmenttilted15degrees
withprotectionagainstdrippingliquid).
Accordingtothemethodsofsterilization
ordisinfection:
Non‐sterilizable.Useofliquidsurface
disinfectantsonly.
Accordingtothemodeofoperation: Continuousoperation
Equipmentnotsuitableforuseinthepresenceofflammableanestheticmixturewithair
orwithoxygenornitrousoxide.

4 989803173791 Rev 0.6
Proprietary Information
Thisdocumentandtheinformationcontainedinitisproprietaryandconfidentialinformationof
Invivoandmaynotbereproduced,copiedinwholeorinpart,adapted,modified,disclosedto
others,ordisseminatedwithoutthepriorwrittenpermissionofInvivo.Thisdocumentis
intendedtobeusedbycustomersandislicensedtothemaspartoftheirInvivoequipment
purchase.Useofthisdocumentbyunauthorizedpersonsisstrictlyprohibited.
Invivoprovidesthisdocumentwithoutwarrantyofanykind,impliedorexpressed,including,but
notlimitedto,theimpliedwarrantiesofmerchantabilityandfitnessforaparticularpurpose.
Invivohastakencaretoensuretheaccuracyofthisdocument.However,Invivoassumesno
liabilityforerrorsoromissionsandreservestherighttomakechangeswithoutfurthernoticeto
anyproductshereintoimprovereliability,function,ordesign.Invivomaymakeimprovementsor
changesintheproductsorprogramsdescribedinthisdocumentatanytime.
Neweditionsofthisdocumentwillincorporateallmaterialupdatedsincethepreviousedition.
Updatepackagesmaybeissuedbetweeneditionsandcontainreplacementandadditionalpages.
Notethatpageswhicharerearrangedduetochangesonapreviouspagearenotconsidered
revised.
Thedocumentationpartnumberandrevisionindicatethecurrentedition.Theprintingdate
changeswhenanewrevisionisprinted.(Minorcorrectionsandupdateswhichareincorporated
atreprintdonotcausethedatetochange.)Thedocumentrevisionletterchangeswhen
extensivetechnicalchangesareincorporated.

Contents
989803173791 Rev 0.6Contentsi
Chapter 1: Important Information
Intended Audience. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Conventions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
System Conventions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Document Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Cautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
SpO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Power. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Miscellaneous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Safety. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Electromagnetic Compatibility (EMC). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Radios . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
EMC Emissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
EMC Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Recommended Separation Distances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Battery Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Disposing of Batteries in Europe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Disposing of Batteries in the United States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
List of Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Unpacking the System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Examining the Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Carry Case. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Mount Adapter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Roll Stand . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Chapter 2: Getting Started
System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Battery Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Using Batteries Safely . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Main Battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Module Battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Charging Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Monitor Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Wireless SpO2 Module Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Assigning the Module Network. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Changing the Module Network Setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Initial System Power-Up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Display Panel Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Chapter 3: Preparation for Use
Using the Monitor. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
System Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

iiContents 989803173791 Rev 0.6
Navigating the Menu Groups and Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Controlling Menu Changes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Locking and Unlocking the Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Patient Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Setup Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Service Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Network Menu. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Alarm Limits Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Sound Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Chapter 4: Monitoring SpO2
SpO2 Sensor and Wireless SpO2 Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Connecting the Sensor and Attachments to the WSpO2 Module. . . . . . . . . . . . . . . . . . . . . . . 52
Patient Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Applying and Positioning the SpO2 Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Positioning the WSpO2 Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Measuring SpO2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Waveform and Vital Sign Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
No Data Available Indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Assessing Suspicious SpO2 Readings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Perfusion Index Value . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Managing Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Alarm Types, Priorities and Indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Physiological Alarm Violations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Technical Alarm Violations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Alarm Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
System Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Chapter 5: Workflow
Workflow Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Chapter 6: Maintenance and Repair
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Cleaning the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Cleaning the Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Appendix A: Specifications
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Patient Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Dimensions and Weights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .78
Display (LCD) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Displayed Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

989803173791 Rev 0.6Contentsiii
Pulse Oximeter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Alarm Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Power Adapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Appendix B: Warranty
Warranty Statement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Appendix C: Regulatory Information
European Union. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Declaration of Conformity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Authorized Representative. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Appendix D: Guidelines and References
Guidelines for the Prevention of Excessive Heating And Burns Associated with Magnetic Reso-
nance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Notes

ivContents 989803173791 Rev 0.6

989803173791 Rev 0.6Chapter1:ImportantInformation1
Chapter 1: Important Information
Informationregardingthesafety,accessories,installation,andoperationofafullyequipped
EssentialMRIPatientMonitor(Model865353)isincludedinthismanual.Foradditional
informationaboutyouraccessories,pleaseconsultthedocumentationthataccompaniesthe
accessory.
Thisproductwillperforminconformitywiththedescriptioncontainedinthismanualand
accompanyinglabelingwhenassembled,operated,maintained,andrepairedinaccordancewith
theinstructionsprovided.
Thisdevicemustbecheckedperiodically.Amalfunctioningdevicemustnotbeused.Partsthat
arebroken,missing,plainlyworn,distorted,orcontaminatedmustbereplacedimmediately.
Referthedevicetoqualifiedservicepersonnelforrepairorreplacement.Thisdeviceoranyofits
partsmustnotberepairedotherthaninaccordancewithwritteninstructionsprovidedbythe
manufacturer.ThedeviceshallnotbealteredwithoutwrittenapprovalofInvivo.Theuserhas
thesoleresponsibilityforanymalfunctionwhichresultsfromimproperuse,faultymaintenance,
improperrepair,damageoralterationbyanyoneotherthanInvivoorInvivo‐authorizedservice
personnel.
Intended Audience
TheEssentialMRIPatientMonitor(Model865353)isintendedforusebyhealthcare
professionalstrainedintheuseoftheequipmentandvitalsignsmonitoring.
Warnings
BeforeusingtheEssentialMRIPatientMonitor(Model865353),readthewarningshereand
thoseintheSafetysectionbelow.ThewarningsandnotesbelowrefertotheEssentialMRI
PatientMonitor(Model865353)initsentirety.
WARNINGS
• ThoroughlyreadandunderstandtheseInstructionsforUsepriortouse.
•Shockhazardexistsifthesystemisoperatedwithoutcovers.
•UseonlysuppliedpowercordsandconnectonlytoproperlygroundedACoutletsto
avoidelectricalshock.

2Chapter1:ImportantInformation 989803173791 Rev 0.6
WARNINGS
•Patientmotionorpositionoftheaccessoriesmayaffectmeasurementaccuracy.Always
consultaphysicianforinterpretationofmeasurementsprovidedbythesystem.
•Performoperationalverificationpriortouse.Ifthesystemfailstofunctionproperly,
removeitfromuseandcontactInvivoTechnicalSupportpersonnel.
• Screenallpatientsformetallicwires,implants,stents,etc.priortoMRprocedures.These
electricalconductorswillreactwiththeMRenvironmentorwiththeInvivoaccessory(if
applieddirectlyovertheconductor),thusincreasingtheriskofheating.
NOTE
TheEssentialMRIPatientMonitor(Model865353)isnotintendedforuseonapatientbeing
transportedoutsideahealthcarefacility.
Conventions
TheEssentialMRIPatientMonitor(Model865353)usescertainconventionsthroughoutthe
interfacetomakeiteasyforyoutolearnanduse.Thisaccompanyinguserinformationalsouses
documentconventionstoassistyouinfindingandunderstandinginformation.
System Conventions
Theseconventionsareusedinthesystem:
•Operationalcontrolisaccomplishedthroughthedisplaypanel.
•Whencontrolormenuitemsareprovidedonthedisplaypanel,touchingthatcontrolor
itemwillactivateoropenit.
•Toprotectagainstaccidentalchangesofirreplaceabledata,aconfirm/cancelpromptis
associatedwithcertainmenuoptions.Whenapromptisdisplayed,youmustconfirmor
cancelthisaction;otherwise,adelayofapproximately30secondswithoutselectionwillbe
equivalenttoselectingcancel.
Document Conventions
•Allproceduresarenumbered,whileanysub‐proceduresarelettered.Completethesteps
inthesequencepresentedtoensuresuccess.Proceduresareindicatedbythefollowing
table:

989803173791 Rev 0.6Chapter1:ImportantInformation3
•Bulletedlistsindicategeneralinformationaboutaparticularfunctionorprocedure,anddo
notimplyasequentialprocedure.
•Messagesregardingaconditioninthedevicearegivenwithinquotationmarks(“”)spelled
andpunctuatedastheyappearinthesystem,unlessincludedasinformationinatable.
•Controlnames,buttonsandmenuitemsortitlesarespelledandpunctuatedasthey
appearinthesystem.
•Symbolsappearastheyappearonthesystem.
•Selectmeanstotouchortaplightlywithafinger(orstylus)withintheboundariesofa
controlitemonthedisplaypanel.
•Theleftsideofthesystemisonyourleftasyoustandinfrontofthesystem,facingit.The
frontofthesystemisnearestyouasyouoperateit.
•Thefrontofthemoduleisnearestyouasyouoperateit.
Warnings
Warning
WARNING
Warningsprovideinformationyoushouldknowtoavoidinjuringyourself,patientsor
personnel.
Cautions
CAUTION
Cautionsprovideinformationyoushouldknowtoavoiddamagingtheequipmentandsoftware.
Notes
NOTE
Notesprovideadditionalinformationregardingsystemusage.
Step Action
1
2
3

4Chapter1:ImportantInformation 989803173791 Rev 0.6
Accessories
Availableaccessoriesarelistedinthetablesbelow.OnlyuserecommendedInvivopatient
sensors,grips,etc,asotherbrandsmaycompromisethesafetyandaccuracyofthesystem.
SpO2
Power
Description PartNumber
QuickConnectSpO2Clip,Adult 989803166531
QuickConnectSpO2Clip,Pediatric 989803166541
QuickConnectSpO2Grip,Adult,20/box 989803166551
QuickConnectSpO2Grip,Infant,20/box 989803166571
QuickConnectSpO2Grip,Neonatal,20/box 989803166581
QuickConnectSpO2Grip,Pediatric,20/box 989803166561
QuickConnectSpO2Grip,StarterPack 989803167111
QuickConnectSpO2Sensor,MRI 989803161991
WirelessSpO2Module(Expression) 989803163111
WirelessSpO2Module(Precess‐Blueversion) 989803172431
Description PartNumber
MainBattery989803171671
ModuleBattery9065
PowerAdapter 989803171691
PowerCord,Brazil250V989803173901
PowerCord,European220‐230V453564177501
PowerCord,UnitedKingdom220‐240V989803174171
PowerCord,US110V989803168211
PowerCord,Universal220V AS18A

989803173791 Rev 0.6Chapter1:ImportantInformation5
Miscellaneous
Description PartNumber
CarryCase989803171711
MountAdapter 989803171681
RollStand 989803173761
UniversalHolderPoleKit(forusewithRollStand) 989803174281
InformationforUseManual,Chinese,Simplified989803174041
InformationforUseManual,Chinese,Traditional989803174081
InformationforUseManual,Czech989803173911
InformationforUseManual,Dutch989803173921
InformationforUseManual,English989803173791
InformationforUseManual,Finnish 989803173931
InformationforUseManual,French989803173941
InformationforUseManual,German989803173951
InformationforUseManual,Greek 989803173961
InformationforUseManual,Hungarian989803173971
InformationforUseManual,Italian 989803173981
InformationforUseManual,Japanese 989803173991
InformationforUseManual,Norwegian 989803174001
InformationforUseManual,Polish 989803174011
InformationforUseManual,Portuguese 989803174021
InformationforUseManual,Russian 989803174031
InformationforUseManual,Slovak 989803174051
InformationforUseManual,Spanish 989803174061
InformationforUseManual,Swedish 989803174071
InformationforUseManual,Turkish 989803174091
ServiceManual 989803173771

6Chapter1:ImportantInformation 989803173791 Rev 0.6
Safety
Electromagnetic Compatibility (EMC)
Thesystemisintendedforuseintheelectromagneticenvironmentspecifiedbelow.Giventhe
system’selectromagneticemissionsandimmunitycharacteristics,thecustomerortheuser
shouldassurethatthesystemisusedwithinsuchanenvironment.
Radios
FrequencyRange:2402to2482MHz.
ModulationType:GMSK.
MonitorEIRP:4.2dBm(peak).
WSpO2EIRP:0dBm(peak)
EMC WARNINGSEMC WARNINGS
•OperationofthesystemoutsidethespecificationsindicatedinAppendixAmaycause
inaccurateresults.
•Theuseofportableandmobileradio‐frequency(RF)communicationsequipmentcan
affecttheoperationofthisdevice.
•TheuseofaccessoriesandcomponentsotherthanthosespecifiedintheAccessorieslist
accompanyingtheseinstructionsforuse(withtheexceptionofitemssoldbyInvivofor
theequipmentorsystemasreplacementpartsforinternalcomponents)willresultin
increasedemissionsordecreasedimmunityoftheequipmentorsystem.
•Thesystemshouldnotbeusedadjacenttoorstackedwithotherequipment(except
otherInvivoequipment,asdetailedinthisdocument)andthatifadjacentorstackeduse
isnecessary,theequipmentorsystemmustbeobservedtoverifynormaloperationin
theconfigurationinwhichitwillbeused.
•ThesystemneedstobeinstalledandputintoserviceaccordingtotheEMCinformation
providedbelow.PortableandmobileRFcommunicationsequipmentcanaffectmedical
electricalequipment.ThesystemmaybeinterferedwithbyotherequipmentwithCISPR
emissionrequirements.

989803173791 Rev 0.6Chapter1:ImportantInformation7
EMC Emissions
Electromagneticemissionsistheabilityofaproduct,adevice,orasystemtointroduce
intolerableelectromagneticdisturbancesintotheuseenvironment.
GuidanceandManufacturer’sDeclaration–
ElectromagneticEmissions
EmissionsTest Compliance ElectromagneticEnvironment‐Guidance
TheEssentialMRIPatientMonitor(Model865353)isintendedforuseintheelectromagneticenvironment
specifiedbelow.ThecustomerortheuseroftheEssentialMRIPatientMonitor(Model865353)shouldassure
thatitisusedinsuchanenvironment.
RFEmissions
CISPR11 Group1
ThesystemusesRFenergyonlyforitsinternalfunctions.
Therefore,itsRFemissionsareverylowandarenot
likelytocauseanyinterferenceinnearbyelectronic
equipment.
RFEmissions
CISPR11 ClassA
Thesystemissuitableforuseinallestablishments,other
thandomesticestablishmentsandthosedirectly
connectedtothepubliclow‐voltagepowersupply
networkthatsuppliesbuildingsusedfordomestic
purposes.
HarmonicEmissions
IEC61000‐3‐2ClassA
VoltageFluctuations/flicker
emissions
IEC61000‐3‐3
Complies

8Chapter1:ImportantInformation 989803173791 Rev 0.6
EMC Immunity
Electromagneticimmunityistheabilityofaproduct,adevice,orasystemtofunction
satisfactorilyinthepresenceofelectromagneticinterference.
GuidanceandManufacturer’sDeclaration‐ElectromagneticImmunity
ImmunityTest IEC60601
TestLevel
Compliance
Level ElectromagneticEnvironment‐Guidance
TheEssentialMRIPatientMonitor(Model865353)isintendedforuseintheelectromagneticenvironment
specifiedbelow.ThecustomerortheuseroftheEssentialMRIPatientMonitor(Model865353)shouldassure
thatitisusedinsuchanenvironment.
ConductedRF
IEC61000‐4‐6
RadiatedRF
IEC61000‐4‐3
3Vrms
150KHzto80MHz
3V/m
80MHzto2.5GHz
V1=3Vrms
E1=3V/m
PortableandmobileRFcommunications
equipmentshouldnotbeusedclosertoanypart
ofthesystem(includingcabling)thanthe
recommendedseparationdistance,ascalculated
bytheequationapplicabletothefrequencyof
thetransmitter.Recommendedseparation
distance:
d=(3.5/V1)
d=(3.5/E1)
(80MHzto800MHz)
d=(7/E1)
(800MHzto2.5GHz)
WherePisthemaximumtransmitteroutput
powerratinginwatts(W),accordingtoitsmanu‐
facturer,anddistherecommendedseparation
distanceinmeters(m).
FieldstrengthsfromfixedRFtransmitters,as
determinedbyanelectromagneticsitesurvey,a
shouldbelessthanthecompliancelevelineach
frequencyrange.b
Interferencemayoccurinthevicinity
ofequipmentmarkedwiththis
symbol:
NOTES
•At80MHzand800MHz,thehigherfrequencyrangeapplies.
•Theseguidelinesmaynotapplyinallsituations,aselectromagneticpropagationisaffectedbyabsorption
andreflectionfromstructures,objectsandpeople.
aFieldstrengthsfromfixedtransmitters,suchasbasestationsforradio(cellular/cordless)telephonesandland
mobileradios,amateurradio,AMandFMradio,andTVbroadcastscannotbepredictedtheoreticallywith
accuracy.ToassesstheelectromagneticenvironmentduetofixedRFtransmitters,anelectromagneticsite
surveyshouldbeconsidered.IfthemeasuredfieldstrengthinthesystemlocationexceedstheapplicableRF
compliancelevelabove,thesystemshouldbeobservedtoverifynormaloperation.Ifabnormaloperationis
observed,additionalmeasuresmaybenecessary,suchasreorientingorrelocatingthesystem.
bOverthefrequencyrange150KHzto80MHz,fieldstrengthsshouldbelessthan3V/m.
P
P
P

989803173791 Rev 0.6Chapter1:ImportantInformation9
Recommended Separation Distances
ThesystemisintendedforuseinanelectromagneticenvironmentwhereradiatedRF
disturbancesarecontrolled.Thecustomeroruserofthesystemcanhelpprevent
electromagneticinterferencebymaintainingaminimumdistancebetweenportableandmobile
RFcommunicationsequipment(transmitters)andthesystemasrecommendedbelow,according
tothemaximumoutputpowerofthecommunicationsequipment.
RecommendedSeparationDistancesbetweenPortableandMobileRFCommunicationsEquipment
andtheSystem
RatedMaximum
OutputPowerof
Transmitter
(W)
SeparationDistanceAccordingtoFrequencyofTransmitter(m)
150KHzto80MHz
d=(3.5/V1)
80MHzto800MHz
d=(3.5/E1)
800MHzto2.5GHz
d=(7/E1)
TheEssentialMRIPatientMonitor(Model865353)isintendedforuseintheelectromagneticenvironment
specifiedbelow.ThecustomerortheuseroftheEssentialMRIPatientMonitor(Model865353)shouldassure
thatitisusedinsuchanenvironment.
0.01 0.117 0.117 0.233
0.1 0.369 0.369 0.738
1 1.167 1.167 2.333
10 3.689 3.689 7.379
100 11.667 11.667 23.333
Fortransmittersratedataminimumoutputpowernotlistedabove,therecommendedseparationdistance(d)
inmeters(m)canbeestimatedusingtheequationapplicabletothefrequencyofthetransmitter,wherePisthe
maximumoutputpowerratingofthetransmitterinwatts(W)accordingtoitsmanufacturer.
NOTES
•At80MHzand800MHz,thehigherfrequencyrangeapplies.
•Theseguidelinesmaynotapplyinallsituations,aselectromagneticpropagationisaffectedbyabsorption
andreflectionfromstructures,objectsandpeople.
P
P
P

10Chapter1:ImportantInformation 989803173791 Rev 0.6
Battery Disposal
Thesystemuseslithiumbatteriesthataresubjecttostrictdisposalregulationsforuserand
environmentalsafety.
Caution
CAUTIONS
•Storebatteriesinadryplace,between0°Cto40°C.
• Neverheatorthrowabatteryintofire.Heatingthebatterywilldamagethesafety
circuitry,whichcancauseruptureorignitionofthebattery.
• Neverdisassemblethebattery.Thebatteriescontainhazardousmaterialthatmustbe
recycledordisposedofproperly.(Refertothedisposalguidelinesbelow.)
Disposing of Batteries in Europe
TheEuropeanCommunity(EC)hasissuedtwodirectivesregardingbatterydisposal:91/157/EEC
and93/86/EEC.Eachmembercountryimplementstheseindependently.Thus,ineachcountry
themanufacturers,importers,andusersareresponsiblefortheproperdisposalorrecyclingof
batteries.Confirmproperdisposalrequirementswithyourhealthcarefacilityordistributor.
Disposing of Batteries in the United States
LithiumbatteriesareneitherspecificallylistednorexemptedfromtheFederalEnvironmental
ProtectionAgency(EPA)hazardouswasteregulations,asconveyedbytheResources
ConservationandRecoveryAct(RCRA).Theonlymetalofpossibleconcerninthebatteryisthe
lithiummetal,whichisnotlistedorcharacterizedasatoxichazardouswaste.Asignificant
amountofspentcellsandbatteriesthatareuntreatedandnotfullydischargedareconsideredas
reactivehazardouswaste.Thus,hazardouswasteofspentcellsandbatteriescanbedisposed
aftertheyarefirstneutralizedthroughanapprovedsecondarytreatmentpriortodisposal(as
requiredbyU.S.LandBanRestrictionoftheHazardousandSolidWasteAmendmentsof1984).
Disposalofspentbatteriesmustbeperformedbyanauthorized,professionaldisposalcompany,
whichhastheknowledgeintherequirementsoftheFederal,theStateandtheLocalauthorities
regardinghazardousmaterials,transportation,andwastedisposal.Confirmproperdisposal
requirementswithyourhealthcarefacility,distributor,and/orlocalEPAoffice.

989803173791 Rev 0.6Chapter1:ImportantInformation11
List of Symbols
Thefollowingsymbolsareusedonthesystem,packingmaterials,andinthisdocument:
Attention,consult
accompanyingdocuments
MRConditional:Useinthe
MRenvironmentisrestricted
tocertainconditionsofuseto
ensurepatientandoperator
safety.
Non‐ionizingradiationNotMRsafe
Poweron/offPercentoxygenpulse
saturation
Productpartnumber Earthground
Alternatingcurrent Antenna
Directcurrent Deviceconformstothe
MedicalDeviceDirective
Productserialnumber WarningShockHazard
Warning/Caution
Dateofmanufacture
YYYY‐MM

12Chapter1:ImportantInformation 989803173791 Rev 0.6
Defibrillator‐ProoftypeCF
equipment(IEC60601‐1)
protectionagainstshock
Attention:Electrostaticsafety
device,observeprecautions
Potentialrestrictionsfor
equipmentincludingradios
mayapplywithinoneormore
European(EU)member
states.
Dangerousvoltage
TypeCFappliedpart Patient
MainbatterygaugeModulebatterygauge
NoBatteryCommunications No(Module)Communications
EnergyStarratedproduct GreenSealproduct
Donotadjustwithout
referringtoservicemanual
Radionetwork(wireless
modules)
NetworkANetwork1
NetworkBNetwork2